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OncoMatch/Clinical Trials/NCT06826768

A Ph Ib Study of REGN5678 Plus Cemiplimab in Patients With mCRPC

Is NCT06826768 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including REGN5678 and Cemiplimab for prostate cancer.

Phase 1RecruitingM.D. Anderson Cancer CenterNCT06826768Data as of May 2026

Treatment: REGN5678 · CemiplimabA single-center phase Ib/II dose escalation and dose-expansion clinical trial of REGN5678 plus cemiplimab

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Must have received: antiandrogen — second-generation

disease progression after at least two lines of systemic therapy, including one line of second-generation anti-androgen therapy

Lab requirements

Blood counts

Hemoglobin ≥8.5 g/dL; ANC ≥1.0 x 10^9/L; Platelet count ≥100 x 10^9/L

Kidney function

Serum creatinine ≤1.5 x ULN or estimated GFR >50 mL/min/1.73 m2

Liver function

Total bilirubin ≤1.5 x ULN (except Gilbert's syndrome); AST ≤2.5 x ULN; ALT ≤2.5 x ULN; ALP ≤2.5 x ULN (≤5 x ULN if tumor liver or bone involvement)

Adequate organ and bone marrow function documented by: Hemoglobin ≥8.5 g/dL; ANC ≥1.0 x 10^9/L; Platelet count ≥100 x 10^9/L. Serum creatinine ≤1.5 x ULN or estimated GFR >50 mL/min/1.73 m2. Adequate hepatic function: Total bilirubin ≤1.5 x ULN; AST ≤2.5 x ULN; ALT ≤2.5 x ULN; ALP ≤2.5 x ULN (≤5 x ULN if tumor liver or bone involvement).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • The University of Texas M. D. Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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